regulatory | pharmaphorum

Tuesday 16 December 2025

regulatory

News

J&J claims FDA's latest national priority voucher

J&J claims FDA's latest national priority voucher

The FDA has awarded its latest national priority voucher to Johnson & Johnson for a combination regimen based on Tecvayli for multiple myeloma.

R&D

Businessman looking at cityscape

Future glances: More change, more tech, more harmonisation

According to Deloitte’s 2026 Life Sciences Outlook Survey, the life sciences sector might be becoming increasingly borderless, but only 41% of responding biopharma and medtech executives fe

News

Raymond Chua of Singapore's Health Sciences Authority and Lawrence Tallon of the UK Medicines and Healthcare products Regulatory Agency.

UK teams up with Singapore on healthtech regulation

A partnership between medicines regulators in the UK and Singapore could allow patients in both countries to access new medical advances more quickly.

News

Agreement reached on EU's new pharma legislation

Agreement reached on EU's new pharma legislation

Agreement has been reached on the reform of EU pharma legislation, but industry thinks it does not go far enough to restore the bloc's global status.

News

FDA set to raise bar for clinical trials of CAR-T therapies

FDA set to raise bar for clinical trials of CAR-T therapies

The FDA could make it harder for developers of CAR-T therapies to bring them to market by requiring full randomised controlled trials.

News

FDA backs first AI tool for use in trials, targeting MASH

FDA backs first AI tool for use in trials, targeting MASH

The FDA has qualified the first AI-based tool that can be used in clinical trials involving patients with MASH to help measure disease activity.